Exhaled Breath Particles in Lung Cancer

Lung Cancer Clinical Trial

Official title:

Exhaled Breath Particles as Biomarkers for Diagnosing, Prognosticating and Evaluating of Non Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05395611
• Other study ID #: PExCaP
• Status: Recruiting
• Start date: January 23, 2018
• Est. completion date: January 2025

Study information

• Verified date: February 2022
• Source: Lund University Hospital
• Contact: Sandra Lindstedt, MD, PhD
• Phone: +46737220580
• Email: sandra.lindstedt_ingemansson[@]med.lu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Lung cancer (CaP) is the leading cause of cancer related deaths on a global level. Early diagnosis is vital for survival and life quality of the affected patients, yet lung cancer is often diagnosed at advanced stages, causing poor five-year survival rates. Exhaled breath particles (EBP) and particle flow rate (PFR) collected by the particles in exhaled air (PExA) system is a safe and easily reproducible non-invasive method for gaining insight into the molecular environment of the distal airways. EBP and PFR have been found useful in detection of other airway diseases such as acute respiratory distress syndrome (ARDS), primary graft dysfunction (PGD) and bronchiolitis obliterans syndrome (BOS). It has been shown that particles found in EBP reflect the general composition of respiratory tract lining fluid (RTLF) and that biomarkers found in EBP correlate to proteins that can be found in both bronchoalveolar lavage fluid (BALF) and plasma. Particle flow rate (PFR) has been found to differ between patients with lung cancer compared to control patients. In the present study the investigators aim to collect EBP samples and measure PFR from patients with primary lung cancer and from control patients. EBPs are collected for molecular analysis. The investigators aim to identify biomarkers for diagnosing, predicting prognosis of and evaluating surgical treatment of non small cell lung cancer.

Description:

EBP samples and measurements of PFR will be collected from patients with primary non-small cell lung cancer (NSCLC) at Skåne University Hospital (SUS) Lund. Measurements will be done at 2 time points, before and after surgical resection for NSCLC.

EBP samples will be collected at one time point from a matched (by age and smoking history) control cohort.

Blood samples will be collected from both cohorts, at the same time points as the EBP/PFR measurements.

Tumor tissue and healthy adjacent lung tissue will be collected from lung cancer patients with tumors greater than 3 cm in diameter on preoperative computed tomography.

The purpose of this clinical trial is to identify non-invasive means of diagnosing NSCLC at earlier stages. The PExA method is not associated with any risks and has potential minimize hospitalization associated with more invasive methods that are in clinical practice today, such as bronchoscopy and biopsies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2025
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 90 Years

Eligibility

Inclusion Criteria:

• Primary lung cancer with clinical Tumor, Node, Metastasis (TNM) up to cT3N1M0 according to TNM 7th edition

• Able to take instructions and perform the standardized breathing maneuver

Exclusion Criteria:

• Dementia

• Severe neurological disease

• Drug abuse

• Heart failure New York Heart Association (NYHA) Classification, NYHA class III or IV

• Ejection fraction < 50 %

• S-creatinine > 140 µmol/L

• Poorly regulated diabetes mellitus

Related Conditions & MeSH terms

• Adenocarcinoma of Lung
• Carcinoma, Non-Small-Cell Lung
• Lung Adenocarcinoma
• Lung Cancer
• Lung Neoplasms
• Non-small Cell Lung Cancer
• Squamous Cell Lung Cancer

Intervention

Other:
• EBPcollected using the PExA device.
The PExA device is a non invasive device that collect particles in exhaled air

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Lund	Skåne Län

Sponsors (1)

Lead Sponsor	Collaborator
Lund University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Behndig AF, Mirgorodskaya E, Blomberg A, Olin AC. Surfactant Protein A in particles in exhaled air (PExA), bronchial lavage and bronchial wash - a methodological comparison. Respir Res. 2019 Sep 26;20(1):214. doi: 10.1186/s12931-019-1172-1. — View Citation

Broberg E, Andreasson J, Fakhro M, Olin AC, Wagner D, Hyllén S, Lindstedt S. Mechanically ventilated patients exhibit decreased particle flow in exhaled breath as compared to normal breathing patients. ERJ Open Res. 2020 Feb 10;6(1). pii: 00198-2019. doi: 10.1183/23120541.00198-2019. eCollection 2020 Jan. — View Citation

Broberg E, Hyllén S, Algotsson L, Wagner DE, Lindstedt S. Particle Flow Profiles From the Airways Measured by PExA Differ in Lung Transplant Recipients Who Develop Primary Graft Dysfunction. Exp Clin Transplant. 2019 Dec;17(6):803-812. doi: 10.6002/ect.2019.0187. Epub 2019 Oct 11. — View Citation

Stenlo M, Hyllén S, Silva IAN, Bölükbas DA, Pierre L, Hallgren O, Wagner DE, Lindstedt S. Increased particle flow rate from airways precedes clinical signs of ARDS in a porcine model of LPS-induced acute lung injury. Am J Physiol Lung Cell Mol Physiol. 2020 Mar 1;318(3):L510-L517. doi: 10.1152/ajplung.00524.2019. Epub 2020 Jan 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protein concentration in exhaled breath particles (EBP)	EBPs are collected on membranes and analyzed in regards to protein concentration and abundance	Before surgery for NSCLC
Primary	Protein concentration in exhaled breath particles (EBP)	EBPs are collected on membranes and analyzed in regards to protein concentration and abundance	After surgery for NSCLC (2 weeks - 36 months)
Primary	Protein concentration in exhaled breath particles (EBP)	EBPs are collected on membranes and analyzed in regards to protein concentration and abundance	In patients without NSCLC (control cohort). (0- 2 weeks)
Secondary	Particle flow rate (PFR) expressed as particles/liter of exhaled air	Particle flow rate (PFR) has recently been shown to differ significantly between patients suffering from respiratory diseases such as bronchiolitis obliterans syndrome (BOS) and covid-19 compared to healthy controls. PFR will be measured from patients with primary lung cancer and control patients to investigate if PFR can be used to distinguish between the two groups and thus help diagnosing lung cancer in earlier stages.	Before surgery for NSCLC
Secondary	Particle flow rate (PFR) expressed as particles/liter of exhaled air	Particle flow rate (PFR) has recently been shown to differ significantly between patients suffering from respiratory diseases such as bronchiolitis obliterans syndrome (BOS) and covid-19 compared to healthy controls. PFR will be measured from patients with primary lung cancer and control patients to investigate if PFR can be used to distinguish between the two groups and thus help diagnosing lung cancer in earlier stages.	After surgery for NSCLC (2 weeks - 36 months)
Secondary	Particle flow rate (PFR) expressed as particles/liter of exhaled air	Particle flow rate (PFR) has recently been shown to differ significantly between patients suffering from respiratory diseases such as bronchiolitis obliterans syndrome (BOS) and covid-19 compared to healthy controls. PFR will be measured from patients with primary lung cancer and control patients to investigate if PFR can be used to distinguish between the two groups and thus help diagnosing lung cancer in earlier stages.	In patients without NSCLC (control cohort). (0- 2 weeks)
Secondary	Protein expression in plasma	Concentration and composition of proteins will be measured in plasma from lung cancer patients	Before surgery for NSCLC
Secondary	Protein expression in plasma	Concentration and composition of proteins will be measured in plasma from lung cancer patients	After surgery for NSCLC (2 weeks - 36 months)
Secondary	Protein expression in plasma	Concentration and composition of proteins will be measured in plasma from healthy control patients	In patients without NSCLC (control cohort). (0- 2 weeks)
Secondary	Protein expression in tissue	Concentration and composition of proteins will be measured in tumor tissue and the surrounding lung tissue.	During surgery for NSCLC. (0- 2 weeks)